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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-01495-1
Product Name/Description SynchroMed II Implantable Drug Infusion Pump

Model Numbers: 8637-20, 8637-40

ARTG Number: 97770
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 22/12/2017
Responsible Entity Medtronic Australasia Pty Ltd
Reason/Issue Medtronic is recalling the prior configuration of SynchroMed II implantable drug infusion pumps, as a new configuration is available with an enhanced motor design. This recall action only relates to unimplanted devices.
Medtronic has received regulatory approval for a design change to the SynchroMed II implantable drug infusion pump. This design change of the motor decreases the potential for intermittent or permanent motor stall which can cause loss of therapy. All SynchroMed II pumps are now being manufactured and distributed with this change.
Recall Action Recall for Product Correction
Recall Action Instructions Medtronic will liaise with hospitals to review their inventory to locate affected pumps. Medtronic will arrange return and replacement of affected pumps.

This action has been closed out on the 22/10/2018.
Contact Information 1800 652 972 - Medtronic Neuromodulation Patient Services